Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs) in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

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Collection and analysis of adverse drug reactions of antiretroviral therapy in a tertiary care hospital in central India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182677 ◽

2018 ◽

Vol 7 (7) ◽

pp. 1326

Author(s):

Sandeep Kumar Adwal ◽

B. L. Bamboria ◽

Ashutosh Chourishi ◽

Aditya Bamboria

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Prospective Observational Study ◽

Causality Assessment ◽

Tertiary Care ◽

Central India ◽

Treatment Interruption ◽

Care Hospital ◽

Drug Reactions ◽

The Common

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

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Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20205127 ◽

2020 ◽

Vol 9 (12) ◽

pp. 1883

Author(s):

Jayendra R. Gohil ◽

Aniket B. Sarwade ◽

Hardik R. Chauhan ◽

Jay R. Jasani ◽

Hinal R. Gujrati

Keyword(s):

Adverse Drug Reactions ◽

Adverse Drug Events ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Pediatric Age Group ◽

Skin Redness ◽

The Common ◽

Probable Category

Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.

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Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20185085 ◽

2018 ◽

Vol 8 (1) ◽

pp. 27

Author(s):

Vijaya Chandra Reddy Konda ◽

Sree Surya Durga Devi Pilla ◽

A. Surekha ◽

K. R. Subash ◽

K. Umamaheswara Rao

Keyword(s):

Adverse Drug Reactions ◽

Continuous Monitoring ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Maculopapular Rash ◽

Drug Reactions ◽

Drug Eruptions ◽

Fixed Drug ◽

The Common ◽

Clinical Patterns

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

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Clinical Profile of Cutaneous Adverse Drug Reactions in a Tertiary Care Centre

IRA-International Journal of Applied Sciences (ISSN 2455-4499) ◽

10.21013/jas.v3.n3.p12 ◽

2016 ◽

Vol 3 (3) ◽

Cited By ~ 1

Author(s):

Priya Prathap ◽

Elsy M.I ◽

Ajitha K. N ◽

Ajith Kumar ◽

Sandhya George

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care ◽

Maculopapular Rash ◽

Clinical Profile ◽

Drug Reactions ◽

Fixed Drug Eruption ◽

Tertiary Care Centre ◽

Dermatology Department ◽

Female Ratio ◽

The Common

<div>Context: Cutaneous adverse drug reactions (cADR) constitute 2-3% of all hospitalized patients. However there is paucity of data regarding occurrence of cADR among out patients. Hence we decided to do a study on clinical profile of cADR and to find out the common drugs resulting in cADR . Objective: To observe the clinical spectrum and the causative drugs of cADR among patients attending Dermatology Department in our hospital. Methods: Patients with cADR who attended Dermatology Out Patient Department (OPD) in our institution were studied for a period of one year.Results:71 patients were diagnosed to have cADR. Male to female ratio was 1.15 :1. Maculopapular rash (22/71 ; 31%) was the commonest presentation followed by generalised pruritus (16/71; 22.5%) , fixed drug eruption( FDE) ( 8/71 ;11.3%) and urticaria (5/71 ;7%). Antimicrobials (40.8%), NSAIDS (22.5%) and Antiepileptics (22.5 %) were the common drugs responsible for these eruptions. </div>

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Adverse drug reactions in therapeutic hypothermia after cardiac arrest

Therapeutic Advances in Drug Safety ◽

10.1177/2042098616679813 ◽

2016 ◽

Vol 8 (3) ◽

pp. 101-111 ◽

Cited By ~ 3

Author(s):

Robert Witcher ◽

Amy L. Dzierba ◽

Catherine Kim ◽

Pamela L. Smithburger ◽

Sandra L. Kane-Gill

Keyword(s):

Cardiac Arrest ◽

Therapeutic Hypothermia ◽

Adverse Drug Reactions ◽

Tertiary Care ◽

Pulseless Electrical Activity ◽

Retrospective Chart Review ◽

Close Monitoring ◽

Drug Reactions ◽

Artery Disease ◽

Grade 3

Background: Therapeutic hypothermia (TH) improves survival and neurologic function in comatose survivors of cardiac arrest. Many medications used to support TH have altered pharmacokinetics and pharmacodynamics during this treatment. It is unknown if or at what frequency the medications used during TH cause adverse drug reactions (ADRs). Methods: A retrospective chart review was conducted for patients admitted to an intensive care unit (ICU) after cardiac arrest and treated with TH from January 2009 to June 2012 at two urban, university-affiliated, tertiary-care medical centres. Medications commonly used during TH were screened for association with significant ADRs (grade 3 or greater per Common Terminology Criteria for Adverse Events) using three published ADR detection instruments. Results: A total of 229 patients were included, the majority being males with median age of 62 presenting with an out-of-hospital cardiac arrest in pulseless electrical activity or asystole. The most common comorbidities were hypertension, coronary artery disease, and diabetes mellitus. There were 670 possible ADRs and 69 probable ADRs identified. Of the 670 possible ADRs, propofol, fentanyl, and acetaminophen were the most common drugs associated with ADRs. Whereas fentanyl, insulin, and propofol were the most common drugs associated with a probable ADR. Patients were managed with TH for a median of 22 hours, with 38% of patients surviving to hospital discharge. Conclusions: Patients undergoing TH after cardiac arrest frequently experience possible adverse reactions associated with medications and the corresponding laboratory abnormalities are significant. There is a need for judicious use and close monitoring of drugs in the setting of TH until recommendations for dose adjustments are available to help prevent ADRs.

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A study on cutaneous adverse drug reactions in a tertiary care center in Rajnandgaon, Chattisgarh

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20194678 ◽

2019 ◽

Vol 5 (4) ◽

pp. 839

Author(s):

Pooja Pandey ◽

Prabhat Pandey ◽

Sharad Manore ◽

Darshan Sandesara

Keyword(s):

Adverse Drug Reactions ◽

Care Center ◽

Tertiary Care ◽

Age Groups ◽

Drug Reactions ◽

Presenting Symptoms ◽

Causative Agents ◽

Life Threatening ◽

Cutaneous Reactions ◽

The Common

Background: Cutaneous reactions are one of the most common types of adverse drug reactions which may vary from mildly discomforting to those that are life-threatening.Methods: This prospective, observational study was done in the department of dermatology. Patients with suspected drug rash, of either sex or all age groups were included in the study.Results: A total of 114 patients were enrolled in the study. The most common presenting symptoms of cutaneous adverse drug reactions (CADRs) were itching, burning sensation and pigmentation with 61.31%, 13.87% and 10.22% respectively. A total of 21 different CADRs were observed. The common causative agents were of anti-microbial, nervous system and musculoskeletal class in both outdoor and indoor patients with 51 (37.22%), 21 (15.32%) and 25 (18.24%) respectively.Conclusions: The most common CADR observed in the study was antimicrobials and NSAIDs were the most common causative drugs.

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Analysis of cutaneous adverse drug reactions in a tertiary care teaching hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20191461 ◽

2019 ◽

Vol 8 (5) ◽

pp. 843

Author(s):

Anusha S. ◽

Nandhini Priya M. ◽

Shanthi N.

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reactions ◽

Tamil Nadu ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Drug Reactions ◽

Female Ratio ◽

Adr Reporting ◽

The Common

Background: Cutaneous Adverse Drug Reaction (CADR) is considered as one of the reasons for discontinuation of drug as well as medication non-adherence. This study analyses the common drugs causing CADR, clinical spectrum of different types of CADR, causality and drugs causing severe CADR.Methods: This was a retrospective cross-sectional observational study conducted by the Department of Pharmacology, Coimbatore Medical College, Coimbatore, Tamil Nadu, India. The study was conducted using data collected in CDSCO’s ADR reporting forms with CADR from June 2015 to July 2017. Patient’s information, details related to adverse drug reaction, suspected medication details, concomitant medication history, causality and seriousness were recorded.Results: A total of 102 CADR were evaluated in this study. The mean age of sample was 37.21±20.33 years. Maximum number of cases was in the age group of 40-49 years. Male to female ratio was 0.96:1. The commonly incriminated drugs causing CADR were antimicrobial agents. Ciprofloxacin (21.57%), phenytoin (9.8%), diclofenac sodium (6.86%), anti-snake venom (6.86%) and vancomycin (3.92%) were the common drugs implicated in CADR. Maculopapular rash and itching were the most common CADR. Anticonvulsants especially phenytoin was commonly associated with severe CADR.Conclusions: The present study has made an impact on all departments of this institution and awareness has been created about spontaneous reporting of all adverse drug reactions in CDSCO ADR reporting forms to the pharmacovigilance centres. Thus, sound knowledge about the adverse drug reactions may decrease the occurrence of drug induced morbidity and mortality.

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Adverse Drug Reactions: Trends in a Tertiary Care Hospital

Current Drug Safety ◽

10.2174/1574886311207050011 ◽

2013 ◽

Vol 7 (5) ◽

pp. 384-388

Author(s):

Harmeet S. Rehan ◽

Deepti Chopra ◽

Ravinder K. Sah ◽

Ritu Mishra

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions

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PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i3.15972 ◽

2017 ◽

Vol 10 (3) ◽

pp. 170 ◽

Cited By ~ 1

Author(s):

Sangeetha Raja ◽

Jamuna Rani R ◽

Kala P

Keyword(s):

Adverse Drug Reactions ◽

Teaching Hospital ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Cross Sectional Study ◽

Sectional Study ◽

Drug Reactions ◽

Cross Sectional ◽

Tertiary Care Teaching Hospital ◽

Care Teaching

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.

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ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2018v10i1.24403 ◽

2018 ◽

Vol 10 (1) ◽

pp. 23

Author(s):

Gajanan P. Kulkarni ◽

Lokesh V. Patil

Keyword(s):

Prospective Study ◽

Adverse Drug Reactions ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Monitoring Centre ◽

Organ Systems ◽

A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

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